s computation has upended communication, financial transactions,manufacturing,media,andtransportation,sotoohas it transformed ophthalmology with the introduction of innovationssuchascross-sectionalimaging,electronicmedicalrecords,and refractive surgery. The past decade has seen increasing miniaturization and the ascendency of mobile devices and distributed computing. In 2017,thepercentageofAmericanswithsmartphonesreached77%and the number of global internet users reached approximately 52% of the world's population. [1][2][3] With this increase in connectivity, patients are demanding improved access to their electronic health information and communication with health care practitioners. Such technology could help close gaps in health care access for rural and underserved areas. Artificial intelligence (AI) and machine learning techniques have experienced a renaissance as improved computational power has enabled the development of deep neural networks. 4,5 This improvement enables highly accurate image classification, natural language processing, and image segmentation. 6 IMPORTANCE The US Food and Drug Administration's medical device regulatory pathway was initially conceived with hardware devices in mind. The emerging market for ophthalmic digital devices necessitates an evolution of this paradigm.OBJECTIVES To facilitate innovation in ophthalmic digital health with attention to safety and effectiveness.EVIDENCE REVIEW This article presents a summary of the presentations, discussions, and literature review that occurred during a joint Ophthalmic Digital Health workshop of the American Academy of Ophthalmology, the American Academy of Pediatrics, the American Association for Pediatric Ophthalmology and Strabismus, the American Society of Cataract and Refractive Surgery, the American Society of Retina Specialists, the Byers Eye Institute at Stanford and the US Food and Drug Administration.FINDINGS Criterion standards and expert graders are critically important in the evaluation of automated systems and telemedicine platforms. Training at all levels is important for the safe and effective operation of digital health devices. The risks associated with automation are substantially increased in rapidly progressive diseases. Cybersecurity and patient privacy warrant meticulous attention.
CONCLUSIONS AND RELEVANCEWith appropriate attention to safety and effectiveness, digital health technology could improve screening and treatment of ophthalmic diseases and improve access to care.